Abstracts

Pregabalin (PGB) is approved for add on therapy for the treatment of partial onset epilepsy. Three double blind placebo controlled trials were completed in over 1052 patients. This report from one epilepsy center provides long term outcome information on patients with refractory seizures treated with PGB., Patients were entered into an open label treatment protocol to obtain information on long term safety and efficacy of PGB. Patients entered the study either after completing a double blind controlled efficacy trial or as [italic]de novo[/italic] patients. During the open label trial patients were requalified to continue if they had a greater than 50% reduction in seizures. The dose of pregabalin could be titrated to a total maintenance dose of 600mg per day. Patients were allowed to continue treatment with 1-3 other medications in addition to the pregabalin. Doses of other antiepileptic medications could be adjusted during treatment., Thirty six total patients were entered into an open label trial. Twenty three (64%) patients dropped for reasons of lack of efficacy, withdrew consent, or adverse events. Thirteen patients (36%) continued in the open label trial. During the trial 6 (16%) patients did not meet requalification criteria and 1 patient dropped out. Six patients were followed until the close of the study in 2005. Three males and three females completed the open label trial. Ages ranged from 28 y.o. to 62 y.o.; two patients were of Hispanic descent, three Caucasian and 1 African American. Seizures began in all patients between age 1 and age 18. Patients had been treated for epilepsy between 4 and 48 years with the majority over 40 years of treatment. Four patients were on 2 antiepileptic drugs when starting the trial 2 patients were on lamotrigine only at enrollment. Patients completing the trial were followed from four to six years total treatment. Three patients were seizure free and the others a marked reduction of seizures ranging from fifty to ninety percent per month. Two patients had an increase in seizure free months. Sixty seven percent of the patients completing the trial continued to have a further reduction in seizures from 48% to 100%. Adverse events reported were few and coincide with data reported from double blind placebo controlled trials. Two patients reported no adverse events, one reported weight gain and double vision was reported by 3 patients at some point during the course of the trial but they continued on drug., Patients maintained on pregablin for greater than 4 years continued to have a greater than 50% reduction in seizure frequency, elimination of other antiepileptic drug doses were achieved during this time period, and patients had few or no adverse effects.,